July 7, 2020

Volume X, Number 189

July 06, 2020

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Precision Medicine - Even Medicare Will Pay For It!

President Barack Obama announced in his 2015 State of the Union address that he was introducing a new Precision Medicine Initiative, supported with over $200 million in the proposed 2016 federal budget. “Precision Medicine” and “Personalized Medicine” are often used as interchangeable terms. Sylvia Burwell, Secretary of the Department of Health and Human Services (HHS), referenced the common description for these terms, and the hopes and expectations for the concepts they reflect, in an HHS blog entry:

The promise of precision medicine is delivering the right treatments, at the right time, to the right person. It is through this promise that we are given one of the greatest opportunities for new medical breakthroughs that we have ever seen.

On September 17, 2015, the federal National Institutes for Health (NIH), one of the operational components of the HHS that is leading implementation of the Precision Medicine Initiative, announced that it intends to enroll one million volunteers from diverse ages, ethnicities and other demographic groups. The information these volunteers provide to NIH will help to identify the risk of disease in certain populations, population responses from commonly used drugs, and biomarkers (in essence, biological “red flags”) that may suggest an increase or decreased risk for developing certain diseases. As another part of the Precision Medicine Initiative, the National Cancer Institute, also a component of HHS, would receive $70 million for advancing targeted oncology treatments under the proposed budget…

It is important to note that many diagnostic tests and targeted therapies are already available for patient use. In fact, many of these tests and therapies have already been approved for payment by the federal Medicare program, typically known as a conservative payer, and one that requires medical necessity and reasonableness as statutory conditions for coverage. For example, genetic testing for certain cancers is addressed in Noridian’s Local Coverage Determination L24308. The Molecular Diagnostic Services Program (MolDX™) was developed in 2012 to identify and establish coverage and reimbursement for molecular diagnostic tests.

“Traditional” healthcare providers (including hospitals, physicians, and oncology centers) are already utilizing personalized medicine’s tools to provide better care for their patients, and patient demand for these exciting technologies is likely to grow with an ever-expanding access to information about their treatment options.

© 2020 Foley & Lardner LLPNational Law Review, Volume V, Number 264


About this Author

Judith Waltz, False Claims Act Attorney, Foley Lardner Law Firm

Judith A. Waltz is a partner and business lawyer with Foley & Lardner LLP. Her practice focuses on government investigations, false claims act, corporate integrity agreements (CIAs), bankruptcy, and Medicare and Medicaid counseling. Ms. Waltz works with clients in various areas of the health care industry. She is former co-chair of the firm’s Life Sciences Industry Team, and former vice chair of the Health Care Industry Team. Ms. Waltz is also a member of the Government Enforcement, Compliance & White Collar Defense and Bankruptcy & Business Reorganizations...